Clinical Investigation of Buttermere (LENS 271) Soft Contact Lenses
United Kingdom73 participantsStarted 2024-08-01
Plain-language summary
The purpose of the study is to compare clinical performance between two soft contact lenses.
Who can participate
Age range8 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
i. Age 8 to 18 years; at least half the population will be children or adolescents aged 8 to 15 years.
ii. Have experience with soft contact lens wear and able to insert and remove soft contact lenses.
iii. Parent/guardian and participant have read and understood the Participant Information Sheet.
iv. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable).
v. Best corrected visual acuity of at least 20/25 in each eye.
vi. Have normal eyes with the exception of the need for visual correction.
vii. Spectacle refraction:
* Age 8 to 12: -0.75D to -4.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D
* Age 13-18: -0.75D to -7.00D spherical equivalent, with cylinder ≤ -0.75D and maximum anisometropia of \<1.00D.
viii. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
Exclusion Criteria:
i. Acute and subacute inflammation or infection of the anterior chamber of the eye.
ii. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
iii. Severe insufficiency of lacrimal secretion (dry eyes).
iv. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
v. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
vi. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lense…
What they're measuring
1
Total Absolute Decentration
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.
2
Contact Lens Centration
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.
3
Contact Lens Movement
Timeframe: At the end of one week daily disposable wear, after at least three hours of wear.